Shanghai, China (Press Release) – On August 8, 2018 Beijing time I-Mab Bio­pharma ("I-Mab"), a Shanghai-based bio­tech com­pany focused on inno­va­tive biologics in on­col­ogy and auto­immune dis­ease, and German biopharma com­pany MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX;NASDAQ: MOR) an­nounced to­day that I-Mab has Submitted an inves­ti­ga­tional new drug (IND) appli­ca­tion to China National Drug Admin­istra­tion (CNDA) for TJ202 / MOR202, a human mono­clonal anti­body directed against CD38 for the treat­ment of multiple myeloma.

Multiple myeloma is the sec­ond most common blood cancer world­wide. The patient number has gradually in­­creased in China in recent years due to an in­creas­ingly aging pop­u­la­tion. Yet there are no effective biologics approved in China for this indi­ca­tion and current ther­a­pies have been asso­ci­ated with serious side effects and limited treat­ment efficacy.

TJ202/MOR202 is a mono­clonal anti­body derived from MorphoSys's HuCAL anti­body tech­nology. The anti­body is directed against CD38 on the surface of multiple myeloma cells, and, according to its sug­gested mode of action, recruits cells of the body's immune sys­tem to kill the tumor. Scientific re­search sug­gest that an anti-CD38 anti­body may have thera­peutic poten­tial in other cancers, as well as auto­immune dis­eases.

China recently issued a new round of reform ini­tia­tives to ac­cel­er­ate clin­i­cal trial ap­prov­al for new drugs, especially in on­col­ogy. "The IND sub­mission was done after a suc­cess­ful pre-submission consultation meeting with Center for Drug Evaluation (CDE) of CNDA, which is re­quired under China's new drug reg­u­la­tion, unless waived," said Dr. Joan Shen, Head of R&D at I-Mab.

"CNDA has endorsed the over­all clin­i­cal and regu­la­tory strat­e­gy, as well as the study designs, which should lead to the biologics license appli­ca­tion (BLA)," said Dr. Joan Shen.Through a licensing agree­ment with MorphoSys AG in No­vem­ber 2017, I-Mab gained ex­clu­sive rights to de­vel­op and com­mer­cial­ize TJ202 / MOR202 in Greater China territory, in­­clud­ing main­land China, Hong Kong, Macau and Taiwan.

After observing patient re­sponses in an interim analysis from an ongoing Phase I/IIa trial in patients with re­lapsed/refractory MM in Germany and Austria, MorphoSys decided to sup­port I-Mab to lead clin­i­cal devel­op­ment of TJ202 / MOR202 in Greater China. MorphoSys will con­tinue to eval­u­ate addi­tional other suitable indi­ca­tions for fur­ther global devel­op­ment of TJ202 / MOR202.

Dr. Malte Peters, Chief De­vel­op­ment Officer of MorphoSys AG commented: "We are delighted that our part­ner I-Mab has taken this im­por­tant step in ad­vanc­ing TJ202 / MOR202 into clin­i­cal devel­op­ment in China. We look for­ward to sup­porting I-Mab in devel­op­ing this inves­ti­ga­tional com­­pound with the goal of helping Chinese patients in multiple myeloma, an indi­ca­tion with a high unmet med­i­cal need".

"With a fast-to-market strat­e­gy under the new drug reg­u­la­tion, we hope to bring this inno­va­tive treat­ment to patients as soon as possible," Dr. Shen commented. "MorphoSys and I-Mab plan to con­tin­uously eval­u­ate the poten­tial and fur­ther devel­op­ment of TJ202 in other indi­ca­tions."

About I-Mab Bio­pharma

Having built a world-class R&D capability and highly ex­peri­enced team, I-Mab focuses on discovery and devel­op­ment of First-in-Class and Best-in-Class biologics in the areas of immuno-oncology and immuno-inflammation. The com­pany has already sub­mitted several IND appli­ca­tions and is prepared to submit addi­tional INDs in order to ini­ti­ate clin­i­cal trials in China and the US, in­­clud­ing multiple Phase II and Phase III studies. I-Mab is on a fast track to­ward becoming an end-to-end fully integrated biopharma com­pany. The com­pany has been well recog­nized by capital mar­ket by suc­cess­fully raising US $330 million within two years, the recent Series C financing was rep­re­senting one of the largest amounts ever in C round by an inno­va­tive bio­tech com­pany in China. http://www.i-mabbiopharma.com

About MorphoSys

MorphoSys is a late-stage, bio­pharma­ceu­tical com­pany devoted to the devel­op­ment of inno­va­tive and dif­fer­en­ti­ated ther­a­pies for patients suffer­ing from serious dis­eases. Based on its tech­no­log­i­cal leadership in generating anti­bodies, MorphoSys, to­geth­er with its part­ners, has devel­oped and con­trib­uted to the devel­op­ment of more than 100 prod­uct can­di­dates, of which 29 are cur­rently in clin­i­cal devel­op­ment. This broad pipe­line spans MorphoSys's two business segments: Proprietary De­vel­op­ment, in which MorphoSys invests in prod­uct can­di­dates for its own account, and Partnered Discovery, in which prod­uct can­di­dates are devel­oped ex­clu­sively for a variety of Pharma and Biotech part­ners. In 2017, Tremfya® (guselkumab), mar­keted by Janssen, became the first thera­peutic anti­body based on MorphoSys's pro­pri­e­tary tech­nology to re­ceive mar­ket­ing ap­prov­al for the treat­ment of mod­er­ate to severe plaque psoriasis in the United States, the European Union and Canada. MorphoSys is listed on the Frankfurt Stock Ex­change and on the U.S. stock ex­change Nasdaq under the symbol MOR. For reg­u­lar up­dates about MorphoSys, visit https://www.morphosys.com.

HuCAL®, HuCAL GOLD®, HuCAL PLATINUM®, CysDisplay®, RapMAT®, arYla®, Ylanthia®, 100 billion high poten­tials®, Slonomics®, Lanthio Pharma® and LanthioPep® are registered trademarks of the MorphoSys Group. Tremfya® is a trademark of Janssen Biotech.

This communication con­tains cer­tain for­ward-looking state­ments con­cern­ing the MorphoSys group of com­pa­nies, in­­clud­ing the part­nering ex­pec­ta­tions in con­nec­tion with MOR202 and ex­pec­ta­tions re­gard­ing the fur­ther devel­op­ment of MOR202 in multiple myeloma in Greater China, in­­clud­ing the in­tended targeting of CD38, poten­tial addi­tional indi­ca­tions such as auto­immune dis­eases and sys­temic lupus erythematosus, poten­tial future pay­ments to be made to MorphoSys under the licensing agree­ment for MOR202, assump­tions re­gard­ing the sub­mission of an IND appli­ca­tion to China National Drug Admin­istra­tion (CNDA) for MOR202 as well as ex­pec­ta­tions re­gard­ing the current clin­i­cal phase 1/2a devel­op­ment in multiple myeloma by MorphoSys. The for­ward-looking state­ments con­tained herein rep­re­sent the judg­ment of MorphoSys as of the date of this release and in­volve known and unknown risks and un­cer­tain­ties, which might cause the actual results, fi­nan­cial con­di­tion and liquidity, per­for­mance or achieve­ments of MorphoSys, or industry results, to be ma­teri­ally dif­fer­en­t from any historic or future results, fi­nan­cial con­di­tions and liquidity, per­for­mance or achieve­ments ex­pressed or im­plied by such for­ward-looking state­ments. In addi­tion, even if MorphoSys' results, per­for­mance, fi­nan­cial con­di­tion and liquidity, and the devel­op­ment of the industry in which it op­er­ates are con­sis­tent with such for­ward-looking state­ments, they may not be predictive of results or devel­op­ments in future periods. Among the factors that may result in dif­fer­ences are MorphoSys' ex­pec­ta­tions re­gard­ing the part­nering ex­pec­ta­tions in con­nec­tion with MOR202 and ex­pec­ta­tions re­gard­ing the fur­ther devel­op­ment of MOR202 in multiple myeloma in Greater China, in­­clud­ing the in­tended targeting of CD38, poten­tial addi­tional indi­ca­tions such as auto­immune dis­eases and sys­temic lupus erythematosus, poten­tial future pay­ments to be made to MorphoSys under a licensing agree­ment for MOR202, assump­tions re­gard­ing the sub­mission of an IND appli­ca­tion to China National Drug Admin­istra­tion (CNDA) for MOR202 as well as ex­pec­ta­tions re­gard­ing the current clin­i­cal phase 1/2a devel­op­ment in multiple myeloma by MorphoSys, MorphoSys' reliance on col­lab­o­rations with third parties, estimating the com­mer­cial poten­tial of its devel­op­ment pro­grams and other risks in­di­cated in the risk factors in­cluded in MorphoSys's Reg­is­tra­tion State­ment on Form F-1 and other filings with the US Se­cu­ri­ties and Ex­change Com­mis­sion. Given these un­cer­tain­ties, the reader is advised not to place any undue reliance on such for­ward-looking state­ments. These for­ward-looking state­ments speak only as of the date of pub­li­ca­tion of this doc­u­ment. MorphoSys expressly disclaims any obli­ga­tion to up­date any such for­ward-looking state­ments in this doc­u­ment to reflect any change in its ex­pec­ta­tions with regard thereto or any change in events, con­di­tions or cir­cum­stances on which any such state­ment is based or that may affect the like­li­hood that actual results will differ from those set forth in the for­ward-looking state­ments, unless spe­cif­i­cally re­quired by law or reg­u­la­tion.

Source: I-Mab Bio­pharma.